Hemoglobin A1c Controls Level 1 and 2 (2018-10-10)

Starting date:

October 10, 2018

Posting date:

October 26, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68106

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  Reason
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  Affected products

Affected products

Hemoglobin A1c Controls Level 1 and 2

Reason

A correction to the product IFU in Dec 2016 was never fully announced to end users in Canada. The correction to the labeling materials provides instructions to avoid exposure to light during storage to ensure product stability for the stated 60-day claim. Tosoh has released this recall to officially inform end users of the change that has been included in the IFU of any lots following lot 7055 (Lot 7065 and above).

Affected products